Bruce A. Buckingham, United States of America
Stanford University Pediatric EndocrinologyPresenter of 3 Presentations
COMPARING USE OF THE OMNIPOD® 5 SYSTEM WITH 3 MONTHS OF AUTOMATED INSULIN DELIVERY TO 3 MONTHS IN MANUAL MODE: A POST-HOC CROSSOVER ANALYSIS
- Bruce A. Buckingham, United States of America
- Lisa Norlander, United States of America
- Irl Hirsch, United States of America
- Lauren Huyett, United States of America
- Todd Vienneau, United States of America
- Steven Lowen, United States of America
- Bonnie Dumais, United States of America
- Trang Ly, United States of America
Abstract
Background and Aims
Achieving treatment goals can be challenging for people with type 1 diabetes (T1D) due to the many daily manual tasks and decisions required. During a 3-month single-arm pivotal study of the Omnipod 5 automated insulin delivery system, a 3-month mid-study safety pause provided the opportunity to assess the system in manual mode (MM, algorithm inactive) compared to automated mode (AM, algorithm active) in a post-hoc crossover analysis.
Methods
A subset of adults (14-70y) and children (6-13.9y) with T1D participating in the study completed four distinct phases of therapy: (1) run-in phase with their standard therapy (ST, 14d), followed by use of the Omnipod 5 System in (2) AM, (3) MM (3mo.), and (4) AM. The total duration of AM use was 3 months per participant (phases 2+4 combined). The primary glucose outcome was percent time in range (TIR, 70-180mg/dL, 3.9-10.0mmol/L).
Results
Adults (N=83) and children (N=89) were aged (mean±SD) 36±14y and 10.5±2.1y with T1D duration 16±11y and 4.8±2.7y and baseline A1C 7.3±0.9% and 7.7±0.9%, respectively. TIR was significantly higher during the AM phases compared to ST and MM (Table). Specifically, TIR increased with AM during Phase 2 compared to ST, reduced back to a level comparable to ST during MM in Phase 3, and then increased again when AM resumed in Phase 4 (all p<0.05).
Conclusions
This post-hoc crossover study emphasizes the effectiveness of the Omnipod 5 automated insulin delivery algorithm on glycemic outcomes, beyond pump and CGM use alone.